Well-Being, Psychological Clinical Trial
— PERSISTOfficial title:
Personal Resilience Skills to Improve Surgery Training (PERSIST)
| Verified date | April 2024 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of the current study (PERSIST) is to 1) determine acceptability of an 8-session (16 week) group curriculum on personal resilience skills for residents in the Duke General Surgery Program, and 2) examine changes in professional fulfillment, depression symptomatology, anxiety symptomatology, and self-valuation, and positive wellbeing (flourishing) at the end of the program and 3-month follow-up compared to baseline, 3) examine performance on surgery training metrics compared to the mean performance of non-participants. Participants will be residents active in the Duke General Surgery Program. There will be one group of Junior Assistant Residents (JAR, N = 10) and one group of Senior Assistant Residents (SAR, N =10), which will be conducted separately. At baseline, all participants will complete questionnaires related personal resilience, including professional fulfillment (professional fulfillment, work exhaustion, interpersonal disengagement), depression symptoms, anxiety, symptoms, self-valuation, flourishing, and psychosocial working conditions. At post-treatment (end of session 8), participants will complete the baseline questionnaires (with the exception of psychosocial working conditions), as well as a questionnaire assessing acceptability of the group experience and content. The post-treatment questionnaires will be repeated as a 3-month follow-up. All study activities are considered low risk, and there the training is expected to have the benefit of teaching lasting skills to promote professional and personal resilience. To protect participant confidentiality, surgery staff and faculty will not have access linkage between study variables and participant identity.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 31, 2024 |
| Est. primary completion date | March 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years and older |
| Eligibility | Inclusion Criteria: - The pilot cohort will be composed of junior assistant residents (JAR) and senior assistant residents (SAR) members of the Duke General Surgery Residency Program. Exclusion Criteria: - Because the PERSIST intervention is focused on coaching resilience to the challenges of clinical training, JAR and SAR who will be completing a research year during the intervention period will be excluded from participation. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Program Acceptability as measured by participant attendance in mean percent | Investigators will track participant attendance over the duration of the intervention and report in total mean percent. | Intervention end - 16 weeks | |
| Primary | Program Acceptability as measured by Questionnaire | A questionnaire rating of the experience and value of the 8 content topics in PERSIST using a scale of 5-50 (higher score = higher acceptability). | Intervention end - 16 weeks | |
| Primary | Professional Well-being as measured by the Professional Fulfillment Index (PFI) | Overall professional well-being will be assessed with the Professional Fulfillment Index (PFI), which is scored on a scale of 0-24 (higher score = better outcome). | 3 months post-intervention | |
| Primary | Personal Well-being as measured by the Self-Valuation (S-V) scale | Personal well-being will be assessed with the Self-Valuation scale (S-V), which is scored on a scale of 0-16 (higher score = better outcome). | 3 months post-intervention | |
| Primary | Positive well-being as assessed by the Flourishing Scale (FS) | Positive well-being will be assessed by the Flourishing Scale (FS), which is scored on a scale of 8-56 (higher score = better outcome). | 3 months post-intervention | |
| Primary | Exhaustion as measured by the Professional Fulfillment Index (PFI) | Exhaustion from work will be assessed with the Professional Fulfillment Index (PFI), which is scored on a scale of 0-44 (higher score = worse outcome). | 3 months post-intervention | |
| Primary | Anxiety symptoms as measured by the General Anxiety Disorder-7 questionnaire (GAD-7) | Anxiety symptoms will be assessed using the General Anxiety Disorder-7 questionnaire (GAD-7), which is scored on a scale from 0-21 (higher = worse outcome). | 3 months post-intervention | |
| Primary | Depression symptoms as measured by the 8-item version of the Patient Health Questionnaire (PHQ-8) | Depression symptoms will be assessed using the 8-item version of the Patient Health Questionnaire (PHQ-8), which is scored on a scale from 0-24 (higher = worse outcome). | 3 months post-intervention | |
| Secondary | Clinical and professional competencies measured by milestone achievement in Entrustable Professional Activities (EPA) | Clinical and professional competencies will be assessed by milestone achievement in Entrustable Professional Activities (EPA). EPA scores are core metrics for evaluating resident performance and providing feedback within the General Surgery Program.
Surgery training outcomes occur in the normal course of training and are not expressly collected as part of the PERSIST intervention. ABSITE and EPA scores are core metrics for evaluating resident performance and providing feedback within the General Surgery Program. |
3 months post-intervention | |
| Secondary | Safety outcomes as measured by mean number of Safety Reporting System (SRS) incidents | Safety outcomes will be assessed by mean number of Safety Reporting System (SRS) incidents compared to non-participants. | 3 months post-intervention |